eTMS for PTSD

Overseen By Jessica Florig, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Virginia Polytechnic Institute and State University

Must not be taking: Certain medications

Disqualifiers: Claustrophobia, Pregnancy, Epilepsy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 5 weeks

20 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude participants on certain medications. It's best to discuss your specific medications with the trial coordinators.

What data supports the effectiveness of the treatment eTMS for PTSD?

Research shows that repetitive transcranial magnetic stimulation (rTMS), a component of eTMS, has been effective in treating major depression and has shown some promise in improving symptoms of PTSD, especially when combined with other therapies like Cognitive Processing Therapy. ^{1 2 3 4 5}

Is eTMS (or TMS) safe for humans?

Repetitive transcranial magnetic stimulation (rTMS), which is similar to eTMS, is considered safe for treating conditions like depression and PTSD. Research over the past 15 years supports its safety, especially when targeting specific brain areas. ^{2 4 6 7 8}

How is the eTMS treatment for PTSD different from other treatments?

eTMS (EEG-enhanced Transcranial Magnetic Stimulation) is unique because it combines brain stimulation with EEG (a test that measures electrical activity in the brain) to potentially enhance treatment outcomes. Unlike traditional therapies, it uses magnetic fields to stimulate specific brain areas, which may help improve PTSD symptoms by targeting brain activity directly. ^{1 2 3 7 9}

What is the purpose of this trial?

A battery of physiological and behavioral data will be collected before and after application of eTMS. Participants will be veterans or first responders diagnosed with PTSD. Study will be a double-blind, sham-controlled, parallel group, randomized clinical trial.

Research Team

Wynn Legon, PhD

Principal Investigator

Virginia Polytechnic Institute and State University

Eligibility Criteria

This trial is for veterans and first responders who have been diagnosed with PTSD. Participants must meet certain health criteria to join, but specific inclusion and exclusion details are not provided.

Inclusion Criteria

Veteran or first responder diagnosed with post-traumatic stress disorder with PCL-5 cutoff of 31 or above

Exclusion Criteria

Claustrophobia

Pregnant

Unable to calculate EEG alpha frequency

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Treatment Testing

Participants undergo 2 days of extensive testing including MRI, OPM, EEG, behavioral tasks, questionnaires, and an EEG sleep study

1 week

2 visits (in-person)

Treatment

Participants receive either active or sham eTMS application

5 weeks

Post-Treatment Testing

Participants undergo 2 days of extensive testing after eTMS application, including MRI, OPM, EEG, behavioral tasks, questionnaires, and an EEG sleep study

1 week

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• eTMS

Trial Overview The study tests eTMS, a personalized brain stimulation treatment, on individuals with PTSD. It's a double-blind trial meaning neither the participants nor the researchers know who gets real treatment or placebo. The effects are measured before and after treatment.

Participant Groups

Group I: eTMS Experimental Treatment 1 Intervention

The active side of a TMS coil will be used to administer eTMS application.

Group II: eTMS sham Placebo Group 1 Intervention

The sham side of a TMS coil will be used to administer a sham dosage of eTMS application.

eTMS is already approved in United States, European Union for the following indications:

Approved in United States as TMS for:

• Major Depressive Disorder (MDD)
• Obsessive-Compulsive Disorder (OCD)
• Migraines
• Anxiety with depression
• Smoking dependence
• Bipolar depression
• Depression in adolescents 15 years and older

Approved in European Union as TMS for:

• Depression
• Obsessive-Compulsive Disorder (OCD)
• Migraines
• Anxiety disorders

Who Is Running the Clinical Trial?

Virginia Polytechnic Institute and State University

Lead Sponsor

Trials

162

Recruited

26,900+

Wave Neuroscience

Industry Sponsor

Trials

14

Recruited

1,000+

Findings from Research

In a study of 12 patients with both PTSD and major depression, 75% experienced a significant improvement in depression symptoms after receiving repetitive transcranial magnetic stimulation (rTMS) over 10 days.

While rTMS showed effectiveness in alleviating depression and related symptoms like anxiety and insomnia, it had only minimal impact on the core symptoms of PTSD, suggesting that different treatment approaches may be needed for mood and PTSD symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repetitive transcranial magnetic stimulation treatment of comorbid posttraumatic stress disorder and major depression. Rosenberg, PB., Mehndiratta, RB., Mehndiratta, YP., et al.[2006]

This pilot study involving 8 veterans with PTSD shows that combining repetitive transcranial magnetic stimulation (rTMS) with prolonged exposure (PE) therapy is safe and feasible, with a dropout rate similar to traditional PE therapy.

While the overall improvement in PTSD symptoms was not statistically significant, veterans with comorbid major depression experienced notable benefits from rTMS, suggesting potential for enhanced treatment outcomes in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exposure Therapy and Simultaneous Repetitive Transcranial Magnetic Stimulation: A Controlled Pilot Trial for the Treatment of Posttraumatic Stress Disorder. Fryml, LD., Pelic, CG., Acierno, R., et al.[2020]

In a study of 29 individuals with comorbid major depressive disorder (MDD) and posttraumatic stress disorder (PTSD), machine learning analysis of EEG coherence was able to predict clinical outcomes after TMS treatment, with a high area under the curve of 0.83 for MDD and 0.71 for PTSD.

The study demonstrated that EEG coherence could effectively differentiate between pre- and post-TMS treatment states, achieving an accuracy of around 75-78% across different brain wave frequencies, suggesting potential for EEG as a screening tool for TMS candidates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of machine learning in predicting clinical response to transcranial magnetic stimulation in comorbid posttraumatic stress disorder and major depression: A resting state electroencephalography study. Zandvakili, A., Philip, NS., Jones, SR., et al.[2021]

In a study of 20 male combat veterans with treatment-resistant PTSD, repetitive transcranial magnetic stimulation (rTMS) significantly reduced hyperarousal symptoms, suggesting its potential effectiveness for this specific symptom.

However, rTMS did not show significant improvements in overall PTSD symptoms or co-occurring depression and anxiety scores, indicating that while it may help with hyperarousal, further research is needed to understand its broader efficacy in PTSD treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is transcranial magnetic stimulation effective in treatment-resistant combat related posttraumatic stress disorder? Oznur, T., Akarsu, S., Celik, C., et al.[2014]

In a study involving 103 veterans with combat-related PTSD, those who received repetitive Transcranial Magnetic Stimulation (rTMS) before Cognitive Processing Therapy (CPT) experienced significantly greater reductions in PTSD symptoms compared to those who received sham rTMS.

The benefits of combining rTMS with CPT were not only evident during treatment but also sustained for up to six months after the therapy, indicating a lasting impact on symptom relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repetitive TMS to augment cognitive processing therapy in combat veterans of recent conflicts with PTSD: A randomized clinical trial. Kozel, FA., Motes, MA., Didehbani, N., et al.[2018]

A survey of 152 service members and veterans revealed that cranial electrotherapy stimulation (CES) led to clinical improvements of 25% or more in anxiety (66.7%), PTSD (62.5%), insomnia (65.3%), and depression (53.9%).

Participants overwhelmingly perceived CES as safe (99.0%), and those not on prescription medications found it more effective than when combined with medication, highlighting CES as a promising noninvasive treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Military service member and veteran self reports of efficacy of cranial electrotherapy stimulation for anxiety, posttraumatic stress disorder, insomnia, and depression. Kirsch, DL., Price, LR., Nichols, F., et al.[2015]

Repetitive transcranial magnetic stimulation (rTMS) is a safe treatment option for depression and shows potential for alleviating symptoms of post-traumatic stress disorder (PTSD), particularly when applied to the right dorsolateral prefrontal cortex.

High-frequency rTMS appears to be more effective than low-frequency rTMS in treating PTSD symptoms, possibly by increasing levels of brain-derived neurotrophic factor, which supports brain health and function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Repetitive transcranial magnetic stimulation treatment for post-traumatic stress disorder]. Jensen, BS., Ashkanian, M.[2018]

In a study involving 24 PTSD patients, high-frequency repetitive transcranial magnetic stimulation (rTMS) at 10 Hz significantly improved core PTSD symptoms and alleviated anxiety over 10 daily sessions.

The results indicate that rTMS targeting the right dorsolateral prefrontal cortex is more effective than low-frequency or sham stimulation, suggesting its potential as a therapeutic intervention for PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repetitive transcranial magnetic stimulation of the right dorsolateral prefrontal cortex in posttraumatic stress disorder: a double-blind, placebo-controlled study. Cohen, H., Kaplan, Z., Kotler, M., et al.[2022]

Bilateral sequential theta-burst stimulation (bsTBS) was well tolerated in a small study of 8 military veterans with treatment-resistant depression (TRD) and comorbid PTSD, showing promising remission rates of 25% and response rates of 38% for depression scores.

The study suggests that bsTBS may be a viable therapeutic option for patients with TRD and PTSD, indicating the need for larger studies to further evaluate its efficacy compared to other rTMS treatment paradigms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bilateral sequential theta burst stimulation in depressed veterans with service related posttraumatic stress disorder: a feasibility study. Vaithianathan, T., Blair, M., Soares, V., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Repetitive transcranial magnetic stimulation treatment of comorbid posttraumatic stress disorder and major depression. [2006]

2. United States pubmed.ncbi.nlm.nih.gov

Exposure Therapy and Simultaneous Repetitive Transcranial Magnetic Stimulation: A Controlled Pilot Trial for the Treatment of Posttraumatic Stress Disorder. [2020]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Use of machine learning in predicting clinical response to transcranial magnetic stimulation in comorbid posttraumatic stress disorder and major depression: A resting state electroencephalography study. [2021]

4. Saudi Arabia pubmed.ncbi.nlm.nih.gov

Is transcranial magnetic stimulation effective in treatment-resistant combat related posttraumatic stress disorder? [2014]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Repetitive TMS to augment cognitive processing therapy in combat veterans of recent conflicts with PTSD: A randomized clinical trial. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Military service member and veteran self reports of efficacy of cranial electrotherapy stimulation for anxiety, posttraumatic stress disorder, insomnia, and depression. [2015]

7. Denmark pubmed.ncbi.nlm.nih.gov

[Repetitive transcranial magnetic stimulation treatment for post-traumatic stress disorder]. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Repetitive transcranial magnetic stimulation of the right dorsolateral prefrontal cortex in posttraumatic stress disorder: a double-blind, placebo-controlled study. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Bilateral sequential theta burst stimulation in depressed veterans with service related posttraumatic stress disorder: a feasibility study. [2022]